EUCTR2015-002536-41-GB进行中（未招募）1 期
A phase II, randomised, double blind, placebo controlled, six way crossover study to assess the bronchodilator effect of RPL554 administered on top of salbutamol and ipratropium in patients with COPD - The effects of RPL554 on top of standard COPD reliever medications
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •2.Male or female aged between 40 and 70 years inclusive, at the time of informed consent.
- •3.If male: must be willing, able and agree to meet the following from the first dose up to 1 month after the last dose of study treatment:
- •Not donate sperm
- •Either: be sexually abstinent in accordance with a patient’s usual and preferred lifestyle (but agree to abide by the contraception requirements below should their circumstances change)
- •Or: use a condom with all sexual partners. If the partner is of childbearing potential the condom must be used with spermicide and a second reliable form of contraception must also be used (e.g. diaphragm/cap with spermicide, established hormonal contraception, intra-uterine device)
- •If female: be of non-childbearing potential defined as being:
- •Either: postmenopausal (being spontaneously amenorrhoeic for at least 1 year with an appropriate clinical profile [e.g. age appropriate, history of vasomotor symptoms]. However, if indicated, this should be confirmed by follicle stimulating hormone levels consistent with postmenopausal status [according to local laboratory ranges]) Or: Permanently sterilised e.g. tubal occlusion, hysterectomy, bilateral oophorectomy, bilateral salpingectomy.
- •4.Have a 12-lead ECG recording at screening (Visit 1) and Visit 2 pre-dose showing the following:
- •Heart rate between 45 and 90 beats per minute
- •QT interval corrected for heart rate using Fridericia’s formula (QTcF) =450 msec
- •QRS interval =120 msec
- •PR interval =220 msec
- •No clinically significant abnormality including morphology (e.g. left bundle branch block, atrio-ventricular nodal dysfunction, ST segment abnormalities)
- •5.Capable of complying with all study restrictions and procedures including ability to use the study nebuliser correctly.
- •6.Body mass index (BMI) between 18 and 33 kg/m2 (inclusive) with a minimum weight of 45 kg.
- •7.COPD diagnosis: Patients with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli and MacNee, 2004) with symptoms compatible with COPD for at least 1 year prior to screening (Visit 1).
- •8.Post-bronchodilator (two puffs of salbutamol followed by two puffs of ipratropium) spirometry at screening (Visit 1):
- •The following must be confirmed at 1 hour post-dose for inclusion:
- •Post-bronchodilator FEV1/FVC ratio of =0.70
- •Post-bronchodilator FEV1 =40 % and =80% of predicted normal
- •The following must be confirmed at either 30 minutes or 1 hour post-dose for inclusion:
- •Demonstrates =150 mL increase from pre-bronchodilator FEV1
- •9.Clinically stable COPD in the 4 weeks prior to screening (Visit 1) and randomisation (Visit 2).
- •10.A chest X-ray (post-anterior [PA]) at screening, or in the 12 months prior to screening showing no abnormalities, which are both clinically significant and unrelated to COPD.
- •11.Meet the concomitant medication restrictions and be expected to do so for t
排除标准
- •1.A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.
- •2.COPD exacerbation requiring oral steroids in the 3 months prior to screening (Visit 1) or prior to randomisation (Visit 2).
- •3.A history of one or more hospitalisations for COPD in the 12 months prior to screening (Visit 1).
- •4.Respiratory tract infection (both upper and lower) treated with antibiotics within 12 weeks of screening (Visit 1) or prior to randomisation (Visit 2).
- •5.Evidence of cor pulmonale or clinically significant pulmonary hypertension.
- •6.Other respiratory disorders: Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnoea, known alpha-1 antitrypsin deficiency or other active pulmonary diseases.
- •7.Previous lung resection or lung reduction surgery.
- •8.Oral therapies for COPD (e.g. oral steroids, theophylline, and roflumilast) in the 3 months prior to screening (Visit 1) and throughout the study.
- •9.History of, or reason to believe a subject has, drug or alcohol abuse within the past 3 years.
- •10.Received an experimental drug within 3 months or five half-lives, whichever is longer.
- •11.Prior exposure to RPL554
- •12.Patients with a history of chronic uncontrolled disease including, but not limited to, cardiovascular (including arrhythmias), endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, haematological, urological, immunological, or ophthalmic diseases that the Investigator believes are clinically significant.
- •13.Documented cardiovascular disease: angina, recent or suspected myocardial infarction, congestive heart failure, a history of unstable, or uncontrolled hypertension, or has been diagnosed with hypertension in the last 3 months.
- •14.Has had major surgery, (requiring general anaesthesia) in the 6 weeks prior to screening (Visit 1), or will not have fully recovered from surgery, or planned surgery through the end of the study.
- •15.History of malignancy of any organ system within 5 years with the exception of localised skin cancers (basal or squamous cell)
- •16.Clinically significant abnormal values for safety laboratory tests (haematology, biochemistry or urinalysis) at screening (Visit 1), as determined by the Investigator.
- •17.A disclosed history, or one known to the Investigator, of significant non-compliance in previous investigational studies or with prescribed medications.
- •18.Requires oxygen therapy, even on an occasional basis.
- •19.Inability to adequately perform whole body plethysmography.
- •20.Any other reason that the Investigator considers makes the subject unsuitable to participate.
- •21.Patients with known hypersensitivity to atropine or its derivatives, or to ipratropium bromide or its excipients.
- •22.Patients with known hypersensitivity to salbutamol or its excipients.
- •23.Patients with known hypersensitivity to RPL554 or its excipients/components.
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